Recall Z-2600-2016 ยท HWC Screw, Fixation, Bone
Integra LifeSciences Corp.
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
| Date | Jul 21, 2016 |
| Status | Terminated |
| Reason | Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw". |
| Root cause | Labeling mix-ups |
| Action | Integra sent an Urgent Voluntary Medical Device Recall letter and acknowledgement return response form dated July 21, 2016 to their affected customers. The recall letter identifies the product and lots involved, problem and actions to be taken. All customers are asked to return the completed acknowledgement and return response form by email to FCA1@integralife.com or fax to 1-609-275-9445. Should any customer has any questions regarding the instructions, they can contact Customer Service at 1-800-654-2873. |
| Quantity | 120 units from multiple lots |
| Distribution | US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071639 | QWIX POSITIONING SCREW Newdeal Sas, Jul 9, 2007 |